Breath analyzer for detecting multiple chemicals

Abstract

A portable breath analyzer includes a base unit that is configured for use with a plurality of interchangeable sensor heads. Each of the sensor heads is removable from the base unit and includes one or more sensor modules configured to detect the presence of one or more chemicals in the exhalation of the user. The sensor modules can be configured to detect the presence of carbon monoxide, alcohol, or other substances indicative of substance abuse disorders. The breath analyzer is battery powered and configured to connect to a smart phone or other computing device through a wireless connection. The mobile computing device can provide instructions to the user and transmit data from the breath analyzer to physicians, treatment counselors, law enforcement and researchers.

Description

BREATH ANALYZER FOR DETECTING MULTIPLE CHEMICALSRELATED APPLICATIONS

[0001] The present application claims the benefit of United States Provisional Patent Application Serial No. 63 / 522,402 entitled “Breath Analyzer for Detecting Multiple Chemicals” filed June 21, 2023, the disclosure of which is incorporated by reference as if fully set forth herein.FIELD OF THE INVENTION

[0002] This application is generally directed at the field of chemical substance identification and more particularly, but not by way of limitation, to a breath sensor configured to detect multiple chemical substances.BACKGROUND OF THE INVENTION

[0003] Alcohol Use Disorder (AUD) and Tobacco Use Disorder (TUD) are medical conditions characterized by a compromised ability to control or cease substance use despite negative social, occupational, or health outcomes. These conditions encompass what is commonly referred to as alcohol and / or tobacco abuse or addiction. The prevalence of AUD is alarmingly high, with millions of individuals worldwide grappling with this disorder. A recent national survey (i.e., the 2021 National Survey on Drug Use and Health) indicated that 29.5 million people in the US had AUD in the past single year. Similarly, TUD remains a persistent and significant public health concern, with approximately 30 million smokers in the country. Tragically, tobacco use is the leading cause of premature death worldwide, claiming over 7 million lives each year, while alcohol use causes approximately 3 million deaths each year worldwide.

[0004] There has been a significant shift towards remote treatments for AUD and TUD that rely on smartphone and phone call-based interventions. Thus, the need for objective verification of smoking and alcohol use is high and growing rapidly. Without objective verification, interventionists and funders (e.g., US government, state governments) cannot know if new interventions actually work. Breath-alcohol and breath-carbon monoxide sensors have emerged as the preferred method for remotely verifying the effectiveness of these interventions. Unfortunately, high-quality carbon monoxide sensors in the market are prohibitively expensive, typically costing around $750-$ 1200 per device. This cost hinders their practical use in large-scale remote trial studies with numerous patient participants. Although lower cost alcohol sensors are commercially available (e.g., $130 per device), they are not linked to platforms that can be easily integrated into interventions. Consequently, thereis a strong demand within the research community for an improved sensing technology to address these limitations.

[0005] Researchers are actively pursuing solutions to overcome these challenges in the treatment of AUD and TUD. In addiction-focused clinical trials, it is important to objectively verify outcomes because people are not always honest about their substance use behaviors. Recent research has highlighted a critical issue with self-reports of abstinence, as individuals frequently misrepresent their substance use by inaccurately claiming abstinence, even when they have recently smoked cigarettes or consumed alcohol. This poses a significant clinical challenge / gap in accurately assessing substance use and devising effective interventions to address these disorders. Overcoming this challenge is vital to ensure accurate monitoring and to develop interventions that can meaningfully support individuals with AUD and TUD. Since the COVID-19 pandemic, many research studies related to substance use and abuse have moved from in-person settings to remote settings. Thus, there is a critical need for a method of remotely verifying recent substance use (e.g., alcohol, smoking, cannabis). It is to these and other deficiencies in the prior art that the present disclosure is directed.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1 is a perspective view of a first embodiment of a multi-substance breath analyzer in communication contact with a mobile computing device.

[0007] FIGS. 2A-2B provide cross-sectional views of the multi-substance breath analyzer of FIG. 1 with the sensor head attached to, and removed from, the base unit.

[0008] FIG. 3 is a side view of a second embodiment of the multi-substance breath analyzer.

[0009] FIG. 4 is a depiction of the multi-substance breath analyzer of FIG. 3 in use with a mobile computing device.

[0010] FIG. 5 is an exploded side view of the second embodiment of the multi-substance breath analyzer.

[0011] FIG. 6 is a perspective bottom view of the upper case of the second embodiment of the multi-substance breath analyzer.DETAILED DESCRIPTION

[0012] In some embodiments, the present disclosure is directed to a remote monitoring system for measuring an analyte in a user's exhalation, in which the remote monitoring system includes a mobile computing device configured to run an application program, and a breath analyzer associated with the mobile computing device through a data connection. In variousembodiments, the breath analyzer includes a primaiy sensor module configured to measure an analyte in the user's exhalation and a verification sensor.

[0013] With reference to the particular embodiments depicted in FIGS. 1 and 2, a multisubstance breath analyzer 100 includes a base unit 102 and a removable sensor head 104. The sensor head 104 includes a mouthpiece 106 that is sized and shaped to encourage the user to exhale through the sensor head 104. The breath analyzer 100 further includes exhaust vents 108 that are configured to discharge the breath that has passed through the sensor head 104 into the base unit 102.

[0014] The sensor head 104 further includes a primaiy sensor module 110 that is designed to detect one or more chemical substances (analytes) from the expired breath of the user. The sensor module 110 can, for example, be configured to detect carbon monoxide (smoking treatment), alcohol (alcohol treatment), cannabinoid (cannabis treatment), and other substances that are of interest in treating substance abuse disorders or other health conditions like asthma, diabetes, compliance with dietaiy plans, and bad breath. For example, recent lab-environment testing has demonstrated the ability of the carbon monoxide specific primary sensor module 110 to accurately detect carbon monoxide at concentration levels as low as Ippm with a resolution of about 0. 1 ppm, which is an order of magnitude better than currently available commercial products.

[0015] The use of interchangeable sensor heads 104 permits the identification of multiple exhaled substances with a single base unit 102. In some embodiments, the breath analyzer 100 is a pocket-sized device that can be easily carried by the user to offer immediate and remote biochemical verification of recent alcohol use, smoking or other conduct subject to a cessation or treatment protocol. The sensor head 104 can be configured for a connection with the base unit 102 through a threaded, magnetic, latched, interference or other mechanism for suitably connecting the sensor head 104 to the base unit.

[0016] The base unit 102 includes a processing module 112, a battery 114 (rechargeable or disposable) and a communication module 116. The batteiy 114 of the breath analyzer 100 provides sufficient power to permit multiple uses of the breath analyzer 100 before the battery 114 is replaced or the unit discarded. In current models, the battery 114 is a common coin-form batteiy that provides sufficient power for hundreds of readings by the breath analyzer 100.

[0017] The communication module 116 is configured to connect via a wired or wireless data connection to a computing device 118. In the exemplary embodiment depicted in FIG. 1, the communication module 116 permits a wireless connection (e.g., Bluetooth) to the mobile computing device 118. The mobile computing device 118 can be a smartphone (as depicted),a tablet, or a laptop computer. In other embodiments, the communication module 116 permits connection of the breath analyzer 100 to a desktop computer. In other embodiments, the communications module 116 has an integrated wireless radio that is configured to transmit and receive data over a cellular or other wireless data network.

[0018] In some embodiments, the breath analyzer 100 connects to the mobile computing device 118 to exchange data with an application program 120 running on the mobile computing device 118. The application program 120 can be configured to provide compliance, verification, logging and reporting functions. In this way, the breath analyzer 100 and the mobile computing device 118 together form a compliance monitoring system 122. The data from the breath analyzer 100 can be collected by the application program 120 on the mobile computing device 118 and transferred to a remote treatment team, law enforcement, courts, researchers, or other interested parties or agencies. In some embodiments, the application program 120 running on the mobile computing device 118 is configured to automatically or periodically remind the user to obtain a reading from the breath analyzer 100. The application program 120 running on the mobile computing device 118 can also be configured to provide guidance (e.g., cessation steps) to the user based on the results produced by the breath analyzer 100. For example, if the breath analyzer 100 detects the presence of carbon monoxide, the mobile computing device 118 can be configured to automatically provide the user with recommendations for addressing urges to smoke, in real-time.

[0019] In some embodiments, the mobile computing device 118 includes one or more identify sensors 124 that are used to verify the identity of the person using the breath analyzer 100. For example, the mobile computing device 118 can include a camera or fingerprint scanner that confirms the identity of the user while the application program 120 is active. In one embodiment, the user is required to position the mobile computing device 118 such that the camera 124 is focused on the user’s face while the user exhales into the breath analyzer 100 (as depicted in FIG. 4). This provides additional confirmation through the application program 120 that the data produced by the breath analyzer 100 originated from the intended user. This prevents a second person from exhaling into the breath analyzer 100 on behalf of the intended user in an attempt to foil monitoring functions of the remote monitoring system 122.

[0020] In some embodiments, the breath analyzer 100 further includes one or more verification sensors 126 that are configured to confirm that the measurements made by the primary sensor module 110 are from the user’s exhalation. In some applications, the verification sensors 126 include temperature sensors, humidity sensors, pressure sensors and contact sensors. The verification sensors 126 confirm that the user is actively exhaling into the breath analyzer 100when measurements are made by the primary sensor module 110. The ability to assess recent alcohol use and smoking while verifying the presence of the user’s breath presents a significant advancement over the prior art.

[0021] In some embodiments, the verification sensors 126 can also be configured to automatically activate the breath analyzer 100 when appropriate readings are made by the verification sensors 126. For example, the verification sensors 126 can be configured to activate the primary sensor module 110 only when sufficient pressure, temperature and humidity readings are made by the verification sensors 126. This ensures that the primary sensor module 110 is not activated before or after the exhalation to reduce sensor error. The verification sensors ensure that measurements are only made while the user exhales into the breath analyzer 100.

[0022] Turning to FIGS. 3-6, shown therein is a second embodiment of the breath analyzer 100 and remote monitoring system 122. To improve remote monitoring functionality, the breath analyzer 100 of this embodiment has an ergonomic offset case 128 in which the mouthpiece 106 extends away from the base unit 102 at an angle. As depicted, the mouthpiece 106 and base unit 102 are oriented in a substantially orthogonal relationship. The offset case 128 includes an upper part 130 and lower part 132 that contain a circuit board 134. The circuit board 134 contains the primary sensor module 110, processing module 112, battery 114 and communication module 116. The design of the offset case 128 is particularly useful because the breath analyzer 100 and the user’s hand do not obscure the user’s face while the breath analyzer 100 is in use (as depicted in FIG. 4). This allows the camera 124 on the mobile computing device 118 to more clearly focus on the user’s face for identity verification purposes.

[0023] In the embodiment depicted in FIGS. 3-6, the upper part 130 of the offset case 128 includes an activation button 136 that activates the breath analyzer 100. The activation button 136 depresses a corresponding power switch 138 on the circuit board 134. As illustrated in FIG. 6, the mouthpiece 106 is integrated into the upper part 130 in a permanent or removable manner. The interior of the mouthpiece 106 is sized and configured to receive the primary sensor module 110 such that exhalation through the mouthpiece 106 is directed into the primary sensor module 110. Additionally, the mouthpiece 106 includes a bypass channel 140 that directs a portion of the user’s exhalation directly onto the verification sensors 126. This design ensures that the verification sensors 126 and primary sensor module 110 receive the same input at the same time.

[0024] For example, when the remote monitoring system 122 is used as part of a smoking cessation or monitoring protocol, the application program 120 can be configured in some embodiments to prompt the user to take a measurement using the breath analyzer 100 while the mobile computing device 118 is positioned to confirm the identity of the user during the measurement with the identity sensors 124. When the user exhales into the mouthpiece 106, the exhalation is directed through the mouthpiece 106 to primary sensor module 110 configured to detect the concentration of carbon monoxide and the verification sensor 126 configured to detect humidity. The breath analyzer 100 processes the measurements made by the primary sensor module 110 and the verification sensor 126 and passes those measurements to the mobile computing device 118. The application program 120 can then log the confirmed measurements and transmit those measurements to a remote clinician.

[0025] The breath analyzer 100 provides a non-invasive and convenient method for health screening that can be easily integrated into standard clinic procedures in medical centers (e.g., assessing carbon monoxide as a vital sign in medical clinics to address the denial by many smokers when confronted by medical professionals). By integrating the breath analyzer 100 into health screening procedures, medical centers can enhance their ability to detect behaviors that increase the probability of negative medical outcomes. Early detection enables prompt intervention and treatment, potentially improving patient outcomes and reducing healthcare costs associated with advanced-stage diseases. Beyond the application for substance user disorder assessment, with the future extended breath analysis functions, such a breath exam procedure can be particularly useful in screening for respiratory and metabolic conditions. For example, the breath analyzer 100 can be configured to detect volatile organic compounds (VOCs) that may indicate lung diseases, such as asthma or chronic obstructive pulmonary disease (COPD). The sensor modules 110 can also be configured to assess metabolic parameters, such as ketone levels for diabetic management or assessing the efficacy of certain medications.

[0026] The breath analyzer 100 empowers health researchers and medical professionals to verify alcohol use and smoking remotely, securely, in real-time, and reliably in research participants and patients. The breath analyzer 100 is an ideal solution for widespread implementation, offering a practical means of assessing substance use while minimizing costs and logistical challenges. Furthermore, the significance of this low-cost sensor has been magnified in the wake of the COVID- 19 pandemic, as remote monitoring of substance use has become paramount due to the shift towards remote research studies. Governments invest billions of dollars into the development of new interventions, and objective measures ofsubstance use can provide invaluable data to determine the effectiveness of interventions based on reliable and unbiased sensor data. Deploying the breath analyzer 100 contributes to the advancement of substance abuse research and intervention effectiveness. This technology enables remote monitoring, facilitates data-driven decision-making, and holds the potential to revolutionize substance use assessments on a large scale.

[0027] Although the breath analyzer 100 has been described above with certain details, it will be understood that the embodiments of the present disclosure are not limited in application to the details of apparatus, component parts, and methods as set forth in the following description. The embodiments of the apparatus, component parts, and methods of the present disclosure are capable of being practiced or carried out in various ways not explicitly described herein. As such, the language used herein is intended to be given the broadest possible scope and meaning; and the embodiments are meant to be exemplary, not exhaustive. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting unless otherwise indicated as so. Moreover, in the following detailed description, numerous specific details are set forth in order to provide a more thorough understanding of the disclosure. However, it will be apparent to a person having ordinary skill in the art that the embodiments of the present disclosure may be practiced without these specific details. In other instances, features which are well known to persons of ordinary skill in the art have not been described in detail to avoid unnecessary complication of the description. While the apparatus, component parts, and methods of the present disclosure have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the apparatus, component parts, and / or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit, and scope of the inventive concepts as described herein. All such similar substitutes and modifications apparent to those having ordinary skill in the art are deemed to be within the spirit and scope of the inventive concepts as disclosed herein.

[0028] All patents, published patent applications, and non-patent publications referenced or mentioned in any portion of the present specification are indicative of the level of skill of those skilled in the art to which the present disclosure pertains, and are hereby expressly incorporated by reference in their entirety to the same extent as if the contents of each individual patent or publication was specifically and individually incorporated herein.

[0029] Unless otherwise defined herein, scientific and technical terms used in connection with the present disclosure shall have the meanings that are commonly understood by those havingordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0030] As utilized in accordance with the methods and compositions of the present disclosure, the following terms and phrases, unless otherwise indicated, shall be understood to have the following meanings: The use of the word "a" or "an" when used in conjunction with the term "comprising" in the claims and / or the specification may mean "one," but it is also consistent with the meaning of "one or more," "at least one," and "one or more than one." The use of the term "or" in the claims is used to mean "and / or" unless explicitly indicated to refer to alternatives only or when the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and "and / or." The use of the term "at least one" will be understood to include one as well as any quantity more than one, including but not limited to, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 100, or any integer inclusive therein. The phrase "at least one" may extend up to 100 or 1000 or more, depending on the term to which it is attached; in addition, the quantities of 100 / 1000 are not to be considered limiting, as higher limits may also produce satisfactory results. In addition, the use of the term "at least one of X, Y and Z" will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y and Z.

[0031] As used in this specification and claims, the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0032] The term "or combinations thereof' as used herein refers to all permutations and combinations of the listed items preceding the term. For example, "A, B, C, or combinations thereof' is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more item or term, such as BB, AAA, AAB, BBC, AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context.

[0033] Throughout this application, the terms "about" or "approximately" are used to indicate that a value includes the inherent variation of error for the apparatus, composition, or the methods or the variation that exists among the objects, or study subjects. As used herein the qualifiers "about" or "approximately" are intended to include not only the exact value, amount,degree, orientation, measuring error, manufacturing tolerances, stress exerted on various parts or components, observer error, wear and tear, and combinations thereof, for example.

[0034] The terms "about" or "approximately", where used herein when referring to a measurable value such as an amount, percentage, temporal duration, and the like, is meant to encompass, for example, variations of ± 25% or ± 20% or ± 10%, or ± 5%, or ± 1%, or ± 0.1% from the specified value, as such variations are appropriate to perform the disclosed methods and as understood by persons having ordinary skill in the art. As used herein, the term "substantially" means that the subsequently described event or circumstance completely occurs or that the subsequently described event or circumstance occurs to a great extent or degree. For example, the term "substantially" means that the subsequently described event or circumstance occurs at least 90% of the time, or at least 95% of the time, or at least 98% of the time.

[0035] As used herein any reference to "one embodiment" or "an embodiment" means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment.

[0036] As used herein, all numerical values or ranges include fractions of the values and integers within such ranges and fractions of the integers within such ranges unless the context clearly indicates otherwise. A range is intended to include any sub-range therein, although that sub-range may not be explicitly designated herein. Thus, to illustrate, reference to a numerical range, such as 1 -10 includes 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, as well as 1.1 , 1.2, 1.3, 1.4, 1.5, etc., and so forth. Reference to a range of 2-125 therefore includes 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37,38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62,63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87,88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109,110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, and 125, as well as sub-ranges within the greater range, e.g., for 2-125, sub-ranges include but are not limited to 2-50, 5-50, 10-60, 5-45, 15-60, 10-40, 15-30, 2-85, 5-85, 20-75, 5-70, 10-70, 28-70, 14-56, 2- 100, 5-100, 10-100, 5-90, 15-100, 10-75, 5-40, 2-105, 5-105, 100-95, 4-78, 15-65, 18-88, and 12-56. Reference to a range of 1-50 therefore includes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, etc., up to and including 50, as well as 1.1, 1.2, 1.3, 1.4, 1.5, etc., 2.1, 2.2, 2.3, 2.4, 2.5, etc., and so forth. Reference to a series of ranges includes ranges which combine the values of the boundaries of different ranges within the series. Thus, to illustratereference to a series of ranges, for example, a range of 1-1,000 includes, for example, 1-10, 10- 20, 20-30, 30-40, 40-50, 50-60, 60-75, 75-100, 100-150, 150-200, 200-250, 250-300, 300-400, 400-500, 500-750, 750-1,000, and includes ranges of 1-20, 10-50, 50-100, 100-500, and 500- 1,000. The range 100 units to 2000 units therefore refers to and includes all values or ranges of values of the units, and fractions of the values of the units and integers within said range, including for example, but not limited to 100 units to 1000 units, 100 units to 500 units, 200 units to 1000 units, 300 units to 1500 units, 400 units to 2000 units, 500 units to 2000 units, 500 units to 1000 units, 250 units to 1750 units, 250 units to 1200 units, 750 units to 2000 units, 150 units to 1500 units, 100 units to 1250 units, and 800 units to 1200 units. Any two values within the range of about 100 units to about 2000 units therefore can be used to set the lower and upper boundaries of a range in accordance with the embodiments of the present disclosure. More particularly, a range of 10- 12 units includes, for example, 10, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, and 12.0, and all values or ranges of values of the units, and fractions of the values of the units and integers within said range, and ranges which combine the values of the boundaries of different ranges within the series, e.g., 10.1 to 11.5. Reference to an integer with more (greater) or less than includes any number greater or less than the reference number, respectively. Thus, for example, reference to less than 100 includes 99, 98, 97, etc. all the way down to the number one (1); and less than 10 includes 9, 8, 7, etc. all the way down to the number one (1).

[0037] The terms "increase," "increasing," "enhancing," or "enhancement" are defined as indicating a result that is greater in magnitude than a control number derived from analysis of a cohort, for example, the result can be a positive change of at least 5%, 10%, 20%, 30%, 40%, 50%, 80%, 100%, 200%, 300% or even more in comparison with the control number. Similarly, the terms "decrease," "decreasing," "lessening," or "reduction" are defined as indicating a result that is lesser in magnitude than a control number, for example, the result can be a negative change of at least 5%, 10%, 20%, 30%, 40%, 50%, 80%, 100%, 200%, 300% or even more in comparison with the control number.

[0038] While the apparatus and methods of this disclosure have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the disclosure. All such similar variations and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the inventive concepts as defined by the appended claims.

Claims

It is claimed:

1. A remote monitoring system (122) for measuring an analyte in a user’s exhalation, the remote monitoring system (122) comprising: a mobile computing device (118) configured to run an application program (120); and a breath analyzer (100) associated with the mobile computing device (118) through a data connection, the breath analyzer (100) comprising: a primary sensor module (110) configured to measure an analyte in the user’s exhalation; and a verification sensor (126).

2. The remote monitoring system (122) of claim 1, wherein the mobile computing device (118) includes an identity sensor (124).

3. The remote monitoring system (122) of claim 2, wherein the mobile computing device (118) is a smartphone and the identity sensor (124) is a camera.

4. The remote monitoring system (122) of claim 1, wherein the primary sensor module (110) is selected from the group consisting of carbon monoxide sensors, alcohol sensors and cannabinoid sensors.

5. The remote monitoring system (122) of claim 1, wherein the breath analyzer (100) further comprises: a base unit (102); a removable sensor head (104); and a mouthpiece (106).

6. The remote monitoring system (122) of claim 5, wherein the primary sensor module (110) is located within the removable sensor head (104).

7. The remote monitoring system (122) of claim 1, wherein the breath analyzer (100) further comprises a verification sensor (126).

8. The remote monitoring system (122) of claim 7, wherein the verification sensor (126) is selected from the group of pressure, humidity, contact and temperature sensors.

9. The remote monitoring system of claim 1, wherein the breath analyzer (100) further comprises: a processing module (112); a communication module (116); and a battery (1 14).

10. The remote monitoring system (122) of claim 1, wherein the breath analyzer (100) further comprises an offset case (128).

11. The remote monitoring system (122) of claim 10, wherein the offset case (128) comprises: an upper part (130), wherein the mouthpiece (106) is connected to the upper part; and a lower part (132).

12. The remote monitoring system (122) of claim 11, wherein the breath analyzer (100) includes a circuit board (134) captured between the upper part (130) and lower part(132).

13. The remote monitoring system (122) of claim 12, wherein the primary sensor module (110) and verification sensor (126) are connected to the circuit board (134) and encased within the mouthpiece (106).

14. The remote monitoring system (122) of claim 13, wherein the mouthpiece (106) includes an internal bypass channel (140) that directs a portion of the user’s exhalation directly onto the verification sensor (126).

15. The remote monitoring system (122) of claim 1, wherein the primary7sensor module (110) can be exchanged by removing and replacing the primary7sensor module (110) from the breath analyzer (100).

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